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510(k) K232201

VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin by bioMerieux, Inc. — Product Code LON

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2023
Date Received
July 25, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device Class
Class II
Regulation Number
866.1645
Review Panel
MI
Submission Type

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Other clearances for product code LON

  • K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (August 21, 2025)
  • K251713 — BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) (August 8, 2025)
  • K250447 — BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 1 (May 19, 2025)
  • K234012 — VITEK COMPACT PRO (March 14, 2025)
  • K250344 — BD Phoenix™ Automated Microbiology System (March 6, 2025)
  • K233986 — BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) (March 15, 2024)
  • K234000 — VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) (March 11, 2024)
  • K232756 — Colibrí (December 27, 2023)
  • K230864 — VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptom (July 5, 2023)
  • K222378 — VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) (June 26, 2023)